The efficacy and safety of ruxolitinib in allogeneic hematopoietic stem cell transplantation for GVHD prophylaxis in siblings aged =40 years: a multicenter, open, randomized, controlled clinical trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Treatment group:PT/CY+ CSA/FK506+RUX;Control group:ATG+CSA/FK506+MMF+MT X; CONDITION: Hematopoietic setm cell transplantation PRIMARY OUTCOME: acute graft‐versus‐host disease; SECONDARY OUTCOME: Incidence of infection;chornic graft‐versus‐host disease;non‐relapse mortality;Overall survival;Disease‐free survival; INCLUSION CRITERIA: ) Age: 40‐65 years old; 2) Gender: both male and female; 3) Patients with hematologic malignancies (including acute leukemia‐CR1, CR2, chronic myeloid leukemia‐CP, and AP) in the standard risk group and myelodysplastic syndromes ‐RA,RARS,RCMD,RAEB‐1, RAEB‐2); 4) HLA‐identical sibling allogeneic hematopoietic stem cell transplantation; 5) In general condition, ECOG score =1 6) Normal cardiac function: ejection fraction =50%; 7) Normal liver and renal function: blood bilirubin =35µmol/L, AST/ALT below 2 times the upper limit of normal value, blood muscle anhydride <= 130 mol/L; 8) Subjects sign informed consent.
Epistemonikos ID: cbd0c4e18604cf885a5b42ac80323da80da237b3
First added on: Feb 20, 2024